EC approval for three rituximab biosimilars

Biosimilars/News | Posted 08/09/2017 post-comment0 Post your comment

On 13 July 2017, three rituximab biosimilars, Blizima, Rituzena (previously Tuxella) and Ritemvia, received European Commission (EC) approval.

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection, and autoimmune disorders.

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 19 May 2017 [1].

All three rituximab biosimilars are produced by South Korean biotechnology company Celltrion. The company also has an infliximab biosimilar approved in Europe, as well as another rituximab biosimilar. Remsima (infliximab) was approved in September 2013 and Truxima (rituximab) was approved in February 2017 [2].

The four-name strategy for rituximab is believed to be a tactic to generate greater total market share for its biosimilar and allow Celltrion to hand out distribution rights to several different companies. The company has already used a similar strategy for its infliximab biosimilar, which has two names – Inflectra and Remsima – with Hospira (now Pfizer) using Inflectra and Celltrion Remsima.

Related article
Biosimilars of rituximab

1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for insulin and rituximab biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 8]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: EMA

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010